NCT01266720

Brief Summary

The purpuse of this study is to assess toxicities of angiogenic peptide vaccine therapy with gemcitabine in treating HLA-A\*0201 restricted patient with non-resectable pancreatic cancer.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6

participants targeted

Target at below P25 for phase_1 pancreatic-cancer

Timeline
Completed

Started Apr 2008

Typical duration for phase_1 pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 24, 2010

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

December 24, 2010

Status Verified

December 1, 2010

Enrollment Period

1.9 years

First QC Date

December 23, 2010

Last Update Submit

December 23, 2010

Conditions

Pancreatic Cancer

Keywords

pancreatic cancerpeptide vaccineVEGFRgemcitabine

Outcome Measures

Primary Outcomes (1)

  • Toxicities as assessed by NCI-CACAE ver3

    3 months

Secondary Outcomes (6)

  • Differences of peptide specific CTL response in vitro among sequence of gemcitabine and peptide vaccine administration

    3 months

  • CD8 population

    3 months

  • Change in level of regulatory T cells

    3 months

  • Objective response rate

    1 year

  • Feasibility

    1 year

  • +1 more secondary outcomes

Study Arms (1)

Phase 1 study

EXPERIMENTAL

Interventions: Biological: VEGFR1, VEGFR2 Drug: Gemcitabine

Biological: VEGFR1, VEGFR2Drug: Gemcitabine

Interventions

VEGFR1, VEGFR2BIOLOGICAL

One mg of each peptide will be administered subctaneously on days 1, 8, 15 and 22

Also known as: VEGFR1 and VEGFR2 specific epitope vaccine
Phase 1 study
GemcitabineDRUG

Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on day 1, 8, 15.

Also known as: Gemzar
Phase 1 study

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • locally advanced or metastatic pancreatic cancer precluding curative surgical resection and recurrent pancreatic cancer
  • Measurable disease by CT scan
  • ECOG performance status 0-2
  • Life expectancy \> 3 months
  • laboratory values as follows: 2,000/mm3 \< WBC \< 15,000/mm3, Platelet count \>75,000/mm3, Total Bilirubin \<1.5 mg/dl, Asparate transaminase \<150IU/L, Alanine transaminase \< 150 IU/L, Creatinine \< 3.0mg/dl
  • HLA-A\*0201
  • Able and willing to give valid written infromed consent

You may not qualify if:

  • Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
  • Breast-feeder
  • Active or uncontrolled infection
  • Prior chemotherapy, radiation therapy, or immunotherapy within 4 weeks
  • Serious or uncured wound
  • Active or uncontrolled other malignancy
  • Steroids or immunosuppressing agent dependent status
  • Interstitial pneumonia
  • Ileus
  • Decision of unsuitableness by principal investigator or physician-in-charge

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fukushima Medical University Hospital

Fukushima, Fukushima, 960-1295, Japan

Location

Related Publications (3)

  • Niethammer AG, Xiang R, Becker JC, Wodrich H, Pertl U, Karsten G, Eliceiri BP, Reisfeld RA. A DNA vaccine against VEGF receptor 2 prevents effective angiogenesis and inhibits tumor growth. Nat Med. 2002 Dec;8(12):1369-75. doi: 10.1038/nm1202-794. Epub 2002 Nov 4.

    PMID: 12415261BACKGROUND

  • Ishizaki H, Tsunoda T, Wada S, Yamauchi M, Shibuya M, Tahara H. Inhibition of tumor growth with antiangiogenic cancer vaccine using epitope peptides derived from human vascular endothelial growth factor receptor 1. Clin Cancer Res. 2006 Oct 1;12(19):5841-9. doi: 10.1158/1078-0432.CCR-06-0750.

    PMID: 17020992BACKGROUND

  • Wada S, Tsunoda T, Baba T, Primus FJ, Kuwano H, Shibuya M, Tahara H. Rationale for antiangiogenic cancer therapy with vaccination using epitope peptides derived from human vascular endothelial growth factor receptor 2. Cancer Res. 2005 Jun 1;65(11):4939-46. doi: 10.1158/0008-5472.CAN-04-3759.

    PMID: 15930316BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Receptor Protein-Tyrosine KinasesGemcitabine

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Protein-Tyrosine KinasesProtein KinasesPhosphotransferases (Alcohol Group Acceptor)PhosphotransferasesTransferasesEnzymesEnzymes and CoenzymesIntracellular Signaling Peptides and ProteinsProteinsAmino Acids, Peptides, and ProteinsReceptors, Cell SurfaceMembrane ProteinsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Mitsukazu Gotoh, MD & PhD

    Fukushima Medical University, Department of Regeneration Surgery

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 23, 2010

First Posted

December 24, 2010

Study Start

April 1, 2008

Primary Completion

March 1, 2010

Study Completion

March 1, 2012

Last Updated

December 24, 2010

Record last verified: 2010-12

Locations

JP(1)